StrataGraft™ skin tissue

StrataGraft™ skin tissue is produced using NIKS™ cells grown under standard operating procedures (SOPs) developed by Stratatech and is rigorously tested and released according to Quality Control and Quality Assurance standards in compliance with current and applicable federal guidelines. This biologically active tissue is suitable for transplantation on patients using traditional surgical suturing techniques. StrataGraft™ skin tissue is an active temporary wound cover that should actively promote wound healing by the patient’s own cells and improve the wound bed to receive autografts (grafts prepared from uninjured segments of the patient’s own skin). The acute wound indication provides advantages for the design and execution of clinical trials needed for regulatory approval.

Unlike other biomaterial-based wound products, StrataGraft™ skin tissue offers both an epidermis and dermis with an epidermal thickness and strength comparable to normal skin. Because the continuous NIKS™ skin cell line has been thoroughly characterized, StrataGraft™ products are virus-free, non-tumorigenic, and offer batch-to-batch genetic consistency. The Company believes these product features will translate into important benefits, which include:

• Increased patient safety due to the virtual elimination of infection risks associated with contaminated “donor” tissues or cadaver skin;
• Reduced pain, discomfort and infection risk due to fast wound closure with a protective human skin substitute;
• Shorter hospital stays and reduced labor intensity resulting in lower costs to healthcare providers.

Clinical Evaluation
Major trauma to the skin and chronic, non-healing wounds are life-threatening injuries that often require immediate surgical intervention. Typically, this involves temporary coverage of the wound site with cadaver skin or synthetic dressings to prevent infection and dehydration. Permanent closure of the wound is generally accomplished through split-thickness skin autografting after the wound bed has healed to the point that it will accept autograft tissue. Although this regimen is the standard of care for severe skin wounds, limited availability of cadaver skin, the potential for transmission of pathogens from donor tissue, and the ultimate rejection of the cadaver skin pose serious drawbacks to this approach. Safe and effective alternatives to the use of cadaver skin are needed to improve the care of patients with these life-threatening wounds. Stratatech Corporation has developed a novel cultured skin substitute tissue, StrataGraft™ skin tissue, for the temporary management of severe skin wounds prior to autografting.

Stratatech Corporation has received clearance from the FDA for Stratatech’s Investigational New Drug Application to conduct a Phase I/II Clinical Trial utilizing StrataGraft™ skin tissue as an alternative to cadaver skin for a temporary wound dressing on acute wounds. StrataGraft™ skin tissue is the first product of its kind to be assessed by the Center for Biologics Evaluation and Research (CBER) at the FDA, which has developed a pre-market review of wound healing products made by combining living human cells with a matrix. To obtain approval from the FDA to begin a trial, the Company successfully completed and documented extensive preclinical testing of StrataGraft™ skin tissue.

Stratatech also has received Institutional Review Board (IRB) clearance at two clinical sites to perform the Phase I/II (safety and efficacy) Clinical Trial of StrataGraft™ skin tissue. StrataGraft™ skin tissue is manufactured under cGMP at the Waisman Clinical BioManufacturing Facility at the University of Wisconsin in sufficient volumes to support this “first in humans” clinical trial. Stratatech has opened enrollment for patients in this clinical study to evaluate the safety and efficacy of StrataGraft™ skin tissue in the temporary management of traumatic skin injuries.